In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML) patients who have reached CR are randomised into two groups and receive high-dose cytarabine (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is evaluated.
In this open-label, randomized, prospective clinical trial, CBF AML(including AML1-ETO or CBF-MYH11 mutated patients) patients who have reached CR are randomised into two groups and receive HDAC or high dose of cytarabine plus chidamide. In experimental group, patients receive cytarabine at a dose of 3g/㎡/d on the first, third and fifth day and chidamide at a dose of 20mg/d twice a week for 3 months.Patients in control group only receive cytarabine at the same dose. The safety and efficacy of chidamide is evaluated. The primary outcome is relapse-free survival rate after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.
Chidamide at a dose of 20mg/d twice a week for 3 months.
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Relapse-Free Survival Rate (RFS)
RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for CBF positive leukemia patients who achieve CR.
Time frame: Within 5 years after randomization
Non-relapse Mortality
Time frame: through treatment completion, an average of 5 months
Overall Survival Rate (OS)
Time frame: Within 5 years after randomization
Cumulative incidence of relapse
Time frame: Within 5 years after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.